Cleared Traditional

NerveTape

K233533 · Biocircuit Technologies, Inc. · Neurology

Feb 2024

Decision

102d

Days

Class 2

Risk

About This 510(k) Submission

K233533 is an FDA 510(k) clearance for the NerveTape, a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Biocircuit Technologies, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 12, 2024, 102 days after receiving the submission on November 2, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number	K233533 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2023
Decision Date	February 12, 2024
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF